(13 days)
The USGI TransPort Endoscopic Guide is intended to be used with an endoscope to facilitate intubation of the endoscope and as a guide for various flexible endoscopic instruments.
USGI Transport™ Endoscopic Access Device
The provided text is a 510(k) premarket notification letter from the FDA regarding the USGI Transport™ Endoscopic Access Device. This type of document primarily confirms substantial equivalence to a predicate device and outlines regulatory compliance. It does not typically contain detailed information about the acceptance criteria or a specific study proving the device meets those criteria, as one would find for a novel device requiring extensive clinical trials.
Therefore, many of the requested fields cannot be directly extracted from this document. However, I will fill in what can be inferred or stated based on the nature of a 510(k) submission.
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified in this document. In a 510(k) submission, acceptance criteria are generally related to demonstrating substantial equivalence to a predicate device in terms of safety and effectiveness, often through performance testing, material characterization, and sometimes limited clinical data. | The FDA determined the device is substantially equivalent to legally marketed predicate devices. This implies that the device's performance, as evaluated against the predicate(s), met the necessary criteria for equivalence in its intended use. Specific performance metrics are not detailed in this letter. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size for Test Set: Not specified in this document. For a 510(k) for an endoscopic access device, testing typically involves mechanical and functional performance tests rather than a "test set" in the context of AI/diagnostic algorithms. If any human-factors or limited animal/human studies were performed for the 510(k), their sample sizes are not detailed here.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable or specified. This device is not an AI/diagnostic device that relies on expert-established ground truth for its performance evaluation in the way a diagnostic algorithm would. Its performance is assessed primarily through engineering and functional testing.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable or specified. As above, this is not a diagnostic device evaluated with expert adjudication methods.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This device is not an AI-assisted diagnostic tool, so an MRMC study is not relevant.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical medical device (endoscopic access device), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the context of AI/diagnostic ground truth. The "ground truth" for this device would be its functional performance specifications, material properties, and compatibility with endoscopes and instruments, as demonstrated through engineering tests and potentially limited animal or ex-vivo studies.
8. The sample size for the training set:
- Not applicable. This device is not an AI/machine learning model, so there is no training set.
9. How the ground truth for the training set was established:
- Not applicable. There is no training set for this type of device.
§ 876.1500 Endoscope and accessories.
(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.